Status:
COMPLETED
Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF
Lead Sponsor:
Biotronik SE & Co. KG
Conditions:
Atrial Fibrillation
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Atrial fibrillation (AF) is the most common arrhythmia encountered in clinical practice. The incidence and prevalence of AF increase exponentially with increasing age and AF is associated with higher ...
Detailed Description
Atrial fibrillation (AF) is the most common arrhythmia encountered in clinical practice; its incidence and prevalence increase exponentially with increasing age and it is associated with increased mor...
Eligibility Criteria
Inclusion
- Symptomatic paroxysmal or persistent atrial fibrillation
- Failure or intolerance of antiarrhythmic drug therapy or unwillingness to take antiarrhythmic drugs
- Left Ventricular Ejection Fraction \<= 35%
- NYHA \>= II
- ICD for primary or secondary prevention with atrial sensing capabilities or Cardiac Resynchronization Therapy plus Defibrillator (CRT-D) device, both with Home Monitoring® technology already implanted
- Patient is willing and able to comply with the protocol and has written informed consent
- Age \>= 18 years
Exclusion
- Contraindication for chronic anticoagulation therapy and heparin
- Documented left atrial diameter \> 6 cm
- Previous left heart ablation procedure for atrial fibrillation
- Acute coronary syndrome, cardiac surgery, angioplasty or stroke within 2 months prior to enrollment
- Untreated hypothyroidism or hyperthyroidism
- Enrollment in another investigational drug or device study
- Woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertility age
- Mental or physical inability to take part in the study
- Listed for heart transplant
- Cardiac assist device implanted
- Planned cardiovascular intervention
- Life expectancy ≤ 12 months
- Uncontrolled hypertension
- Requirement for dialysis due to terminal renal failure
- Participation in another telemonitoring concept
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2017
Estimated Enrollment :
398 Patients enrolled
Trial Details
Trial ID
NCT00643188
Start Date
January 1 2008
End Date
March 1 2017
Last Update
May 18 2017
Active Locations (32)
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1
Royal Adelaide Hospital
Adelaide, Australia
2
Royal Brisbane and Women's Hospital
Herston, Australia
3
A. ö. Krankenhaus der Elisabethinen Linz
Linz, Austria
4
Allgemeines Krankenhaus der Stadt Wien
Vienna, Austria